EUCTR2015-001630-21-BG进行中（未招募）1 期
Efficacy and Safety of Rivaroxaban Prophylaxis Compared with Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 841
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Histologically confirmed solid malignancy including but not limited to: pancreas, lung, stomach, colon, rectum, bladder, breast, ovary, renal or lymphoma (hematologic), with locally advanced or metastatic disease
- •- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 02
- •- Have a Khorana thromboembolic risk Score greater than or equal
- •to (>=) 2
- •- Creatinine clearance (CrCl) >= 30 milliliter per minute (mL/min)
- •-Plan to initiate systemic cancer therapy within ±1 week of receiving the first dose of study drug with the intention of receiving systemic cancer therapy during the double-blind treatment period with for an intended duration determined by the treating oncologist according to standard protocols of clinical care.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 450
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 350
排除标准
- •- Diagnosis of primary brain tumors
- •- Known history of brain metastases
- •- Bleeding diathesis, hemorrhagic lesions, active bleeding, and other conditions with a high risk for bleeding
- •- Hematologic malignancies with the exception of lymphoma
- •- Platelet count less than (<) 50,000/millimeter^3 (mm^3), Life expectancy of less than or equal to (<=) 6 months
研究者
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